NCT00992147已完成2 期
A Phase II/III Clinical Study of ANTG-adip for the Treatment of Depressed Scar to Evaluate Safety and Efficacy
Anterogen Co., Ltd.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2004年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Efficacy: recovery rate(%)
研究概览
简要总结
Autologous cultured adipocytes (ANTG-adip) is produced by well-established techniques including cell harvesting from lipoaspirates, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label, dose-escalation study. Patients are given subcutaneous injection of ANTG-adip and followed for 12 weeks according to the clinical trial protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 19 years
- •depressed scar less than volume of 5 ml
- •negative for urine beta-HCG for women of childbearing age
- •agreement to participate, with signed informed-consent
排除标准
- •failure to meet inclusion criteria
- •any immune-suppressive drug, corticosteroid or cytotoxic drug within the previous 30 days
- •allergy to bovine-derived materials
- •Diagnosis of cancer, AIDS, HBV or HCV.
- •Patient has a lot of hairs or a tattoo on depressed site
- •Insufficient adipose tissue for manufacturing of ANTG-adip
- •Patient has depressed scar caused by a malignant tumor
- •Patient whom investigator consider is not suitable in this study
研究组 & 干预措施
autologous cultured adipocytes
Experimental
干预措施: Adipocell (Drug)
结局指标
主要结局
Efficacy: recovery rate(%)
时间窗: week 12
Safety: clinically measured abnormality of laboratory tests and adverse events, Injection site observation, Immune rejection test
次要结局
- Recovery rate (%)(day 7, 14, 21, 28 days and week 8)
- A digital photograph(day 1, 3, 7, 14, 21, 28, week 8 and week 12)
- Patient satisfaction(week 12)
研究者
研究点 (1)
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